FDA Product Code
FDA Product Code GIF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.8200
510(k) Clearances — 38 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K883989 | KVM ISOTONIC FLUSH SOLUTION | Kvm Technologies, Inc. | 1988-10-12 | Traditional | PDF ↗ |
| K883990 | KVM ISOTONIC DILUENT | Kvm Technologies, Inc. | 1988-10-12 | Traditional | PDF ↗ |
| K882490 | HYCEL QUICK-LYSING HEMOGLOBIN REAGENT | R&D Systems, Inc. | 1988-07-25 | Traditional | PDF ↗ |
| K882267 | SYSMEX QUICKLYSER-II (QLS-200A) | Toa Medical Electronics USA, Inc. | 1988-07-12 | Traditional | PDF ↗ |
| K881130 | CELL-DYN ISOTONIC DILUENT | Abbott Diagnostics | 1988-03-31 | Traditional | PDF ↗ |
| K873347 | CELL-DYN DIFF. SCREEN ISOTONIC DILUENT | Abbott Diagnostics | 1987-09-09 | Traditional | PDF ↗ |
| K851843 | OSMOCEL 3 | Hematology Marketing Assoc. | 1985-07-30 | Traditional | PDF ↗ |
| K851320 | SDI PREPAX DILUKIT M. | Scientific Distributors, Inc. | 1985-07-05 | Traditional | PDF ↗ |
| K851280 | DASS PACK | Dass, Inc. | 1985-07-05 | Traditional | PDF ↗ |
| K850239 | SYSMEX HEMATOLOGICAL WHOLE BLOOD DILUTING REAGENT- | Toa Medical Electronics USA, Inc. | 1985-04-01 | Traditional | PDF ↗ |
| K850095 | LASER-DIL | Hematology Marketing Assoc. | 1985-03-29 | Traditional | PDF ↗ |
| K844782 | NSI ELT-D DILUTING FLUID 4000ML | Nobel Scientific Industries, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K842929 | HAYEM DILUTING FLUID | E K Ind., Inc. | 1984-09-07 | Traditional | PDF ↗ |
| K842068 | IDI ISOTONIC DILUENT | Interscience Diagnostics, Inc. | 1984-07-02 | Traditional | PDF ↗ |
| K841799 | CYANOMETHEMOGLOBIN REAGENT | Reagent Laboratory, Inc. | 1984-05-31 | Traditional | PDF ↗ |
| K840041 | SDI PREPAX DILUKIT HW | Scientific Distributors, Inc. | 1984-03-05 | Traditional | PDF ↗ |
| K840477 | UNITIZED HEMATOLOGY SET 65132/93 | Emd Chemicals, Inc. | 1984-03-05 | Traditional | PDF ↗ |
| K833972 | QUICK-COUNT HEMATOLOGY REAGENT KIT | Seragen Diagnostics, Inc. | 1984-02-17 | Traditional | PDF ↗ |
| K840038 | PREPAX DILUKIT PLUS | Scientific Distributors, Inc. | 1984-02-10 | Traditional | PDF ↗ |
| K840043 | SDI PREPAX DILUKIT CT | Scientific Distributors, Inc. | 1984-02-10 | Traditional | PDF ↗ |
| K833443 | ISOTONIC BLOOD CELL DILUENT J & S | Jasins & Sayles Associates, Inc. | 1983-11-03 | Traditional | PDF ↗ |
| K832116 | ATAC 4700 HEMATOLOGY CELL COUNTER | Turpen Laboratory Systems, Inc. | 1983-10-20 | Traditional | PDF ↗ |
| K831617 | DILUENT | Omega Medical Diagnostics | 1983-06-16 | Traditional | PDF ↗ |
| K830188 | OSMOCEL + | Hematology Marketing Assoc. | 1983-03-01 | Traditional | PDF ↗ |
| K822325 | BLOOD CELL DILUENT 78N 1913 | Interscience, Inc. | 1982-10-18 | Traditional | PDF ↗ |
| K822501 | CDL ISOTONIC DILUENT | Connecticut Diagnostics, Ltd. | 1982-09-17 | Traditional | PDF ↗ |
| K821683 | REAGENT FOR COULTER COUNTER MODEL 5+11 | Fisher Scientific Co., LLC | 1982-06-24 | Traditional | PDF ↗ |
| K812309 | CRYOSAN NORMAL SALINE | Cryosan, Inc. | 1981-09-16 | Traditional | PDF ↗ |
| K801357 | MODIFIED BLOOD CELL COUNTING & LYSING | Coulter Electronics, Inc. | 1980-08-14 | Traditional | PDF ↗ |
| K801346 | NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA | Nobel Scientific Industries, Inc. | 1980-08-12 | Traditional | PDF ↗ |
| K800180 | VARIOUS REAGENTS FOR BLOOD CELL ANALYZER | Laboratory Products, Inc. | 1980-03-19 | Traditional | PDF ↗ |
| K790442 | ISOTONIC DILUENT | Royco Instruments | 1979-04-04 | Traditional | PDF ↗ |
| K790028 | DILUENT, CELLENT BLOOD | Sysmex Corp. | 1979-02-15 | Traditional | PDF ↗ |
| K781008 | ISOTONIC DILUENT | Mallinckrodt Critical Care | 1978-06-28 | Traditional | PDF ↗ |
| K780830 | ISOTONIC BUFFERED SALINE | Harleco | 1978-06-14 | Traditional | PDF ↗ |
| K771787 | AZIDE FREE BLOOD DILUTING REAGENT | J.T. Baker Chemical Co. | 1977-10-07 | Traditional | PDF ↗ |
| K760124 | AUTO CELL DILUENT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1976-07-20 | Traditional | PDF ↗ |
| K760129 | SALINE, ISOTONIC BUFFERED, AZIDE-FREE | Harleco | 1976-07-20 | Traditional | PDF ↗ |
Product code GIF · Class I · Hematology. Data: openFDA.